The present invention relates to a process of making applicators for delivering materials into mammalian body cavities having an indentation in a finger grip region with shoulders on each end of the indentation. The applicator is particularly useful for delivering catamenial devices into a vaginal canal.
Applicators for delivering materials into a body cavity typically comprise a tubular insertion member having an insertion end and a gripper end opposite thereof, and an elongate expulsion member slideably fitted within the tubular insertion member for expelling the contained materials. The gripper end will generally incorporate features to allow a user to more or less securely hold the applicator during usexe2x80x94inserting the applicator into a body cavity, expelling a substantially enclosed material contained by the applicator, and withdrawing the applicator from the body.
Attempts have been made to improve the user""s ability to manipulate the applicator during use. One approach is to significantly reduce the diameter of the applicator in the gripper end, as can be seen in Whitehead, U.S. Pat. No. 4,508,531. Whitehead discloses providing a blank with a plurality of slightly recessed areas outlined by scored lines, which result in a reduced diameter gripping portion when the blank is formed into a tubular structure.
Similar examples can be seen in Huffman, U.S. Pat. No. 4,573,964, and Sheldon, U.S. Pat. No. 4,573,963. Huffman and Sheldon disclose providing a finger gripping portion of a tube with a series of slits, and then compressing the gripping portion to form a shoulder at a singular point of diameter change. While the reduced diameter grip of these applicators may help in preventing fingers from slipping towards the insertion end during the insertion step, there is little or no resistance offered in the opposite direction during the expulsion step. This is a step with which many users have difficulty.
To provide limited resistance to finger slippage during the expulsion step, annular ribs or circumferential ridges can be incorporated in the reduced diameter section, as disclosed in U.S. Pat. Nos. 4,921,474 and 3,831,605. However, in these examples, the projections extend to a lesser degree than a shoulder formed at the interface of the reduced diameter section and the remaining portion of the applicator insertion member. Forces required to expel materials from an applicator can be as great, or greater, than the forces required to place the insertion member into a body cavity, thereby necessitating the need for as great of resistance for the fingers in directions away from the insertion end as that towards the insertion end.
Another approach to improve the grip of the applicator during use is to incorporate projections, such as in the form of a ring, at the base of the applicator member being inserted into the body. Examples of this approach are disclosed in Voss, U.S. Pat. No. 4,361,150 and Sartinoranont, U.S. Pat. No. 4,447,222.
In order for the projections to function as intended, they must be of significant dimension. However, a number of disadvantages are realized as the projection dimensions increase. One disadvantage is the handling of the applicators during high-speed manufacturing. Applicators are transferred from one position to another many times throughout its manufacture, and the projections can become snagged, severely affecting the output efficiency and quality of the products. Another feature of many high-speed manufacturing processes is a buffering system that accumulates materials and products between major steps of manipulation and assembly. Applicators with projections will not stack neatly (parallel) in the buffering systems, thereby negatively affecting the efficiency of space and transfer, and potentially creating a stop in the process due to applicators being xe2x80x9chung upxe2x80x9d in the accumulators or interconnected with adjacent applicators.
A second disadvantage of applicators having projections is related to the packaging of the fully assembled applicators. Just as the applicators will not stack neatly in the buffering systems of high-speed manufacturing equipment, the applicators will not stack neatly in a package of two or more. Either extra packaging material is needed to compensate for nonparallel stacking, or additional equipment and processing steps is required to orient adjacent applicators such that the projections are opposite one another.
In view of the shortcomings of the prior art, what is needed is an applicator which has substantial resistance to finger slip during both applicator insertion into a body cavity and expulsion of material contained by the applicator, and is conducive to high-speed manufacturing and efficient packaging.
The present invention relates to methods of making applicators for delivering materials into body cavities. The applicators are particularly useful for inserting catemenial and prophylactic devices into a vaginal canal. The applicators comprise an elongate insertion member having an insertion end and a gripper end opposite thereof. The gripper end has an indentation with a shoulder on each end of the indentation. The shoulder disposed toward the insertion end provides resistance to finger slip during the step of inserting the applicator into a body cavity, while the shoulder adjacent the gripper end provides resistance to finger slip during the step of expelling material substantially contained by the applicator. The shoulder adjacent the gripper end also provides secure handling of the applicator while removing the applicator from the body after the expulsion step has been completed.
The indented finger grip feature provides additional benefits other than secure handling during use. The indentation provides a quick and easy visual/tactile cue of where to hold the applicator during use. A user""s manual digits are somewhat protected from being significantly soiled with bodily-discharges. Furthermore, the indentation provides a visual/tactile cue of applicator insertion depth, and thereafter tampon positioning within the vaginal canal.
In accordance with one embodiment of the present invention there has now been provided a method of making an applicator for delivering materials into a mammalian body cavity, comprising an elongate insertion member having an indentation in a finger grip region defined by shoulders at each end of the indentation. The method includes providing an elongate insertion member having a gripper end. The gripper end has a first region proximal the gripper end edge, a second region adjacent the first region and distal the gripper end edge, and a third region adjacent the second region. Each region has an initial outside perimeter. The method also includes removing a plurality of discrete sections from the gripper end second region and reducing the outside perimeter of the second region while substantially maintaining the perimeter of the first and third regions. This forms an indented second region defined by a shoulder intermediate each of the first and second regions.
In accordance with a second embodiment of the present invention there has now been provided a method of making an applicator for inserting materials into a body cavity, comprising an elongate insertion member having an indentation in a finger grip region with shoulders on each end of the indentation. The method includes unwinding a rolled sheet-like material and separating the sheet-like material into a plurality of insertion member blanks. Each insertion member blanks has at least one gripper end, and the at least one gripper end has a first region proximal the gripper end, a second region adjacent the first region, and a third region adjacent the second region. The method also includes removing a plurality of discrete sections from the second region while maintaining portions of the material sections residing therebetween. The blank is formed around a mandrel and sealed to form an elongate formed member. The second region is then collapsed to form the indented second region defined by a shoulder intermediate the second region and each of the first and third regions.
Yet another embodiment provided by the present invention, similar to that above, employs the step of forming both the elongate insertion member and the indentation around the same mandrel, wherein the mandrel has a perimeter in a region corresponding to the blank second region which is less than a perimeter in regions corresponding to the blank first and third regions. This embodiment provides the potential for eliminating the need for a separate step to collapse the finger grip second region after the blank has been formed into an elongate member.